India in the Global Regulatory Landscape
India is a member of the IMDRF (International Medical Device Regulators Forum) and has adopted several IMDRF guidance documents into its regulatory framework, including the STED format, UDI framework, and SaMD classification principles.
Key comparisons
| Framework | Regulator | Classification | Market authorisation |
|---|---|---|---|
| India | CDSCO | Class A–D (IMDRF-aligned) | Import licence (Form MD-14/15) |
| Australia | TGA | Class I–III (IVD A–D) | ARTG registration/listing/inclusion |
| EU | European Commission | Class I–III (IVD A–D) | CE marking via Notified Body |
| USA | FDA / CDRH | Class I–III | 510(k), De Novo, PMA |
| Singapore | HSA | Class A–D | HSA product registration |
| Canada | Health Canada | Class I–IV | Medical Device Licence |
See India vs TGA · CE · FDA · HSA · Health Canada for a detailed comparison.